• Lenvima is a brand (trade) name for lenvatinib which is an oral targeted drug treatment used to treat certain cancers. It is not a chemotherapy drug.
• Lenvima (lenvatinib) works by blocking proteins that encourage cancer cell growth. It also inhibits signals to help slow the growth of new blood vessels from existing blood vessels (known as angiogenesis) that support the tumor's growth.
• Lenvima belongs to the class of medicines known as multiple receptor tyrosine kinase (RTK) inhibitors. It may also be called a vascular endothelial growth factor (VEGF)/ vascular endothelial growth factor receptor (VEGFR) inhibitor.

• May be used to treat differentiated thyroid cancer after radioactive iodine has been tried without success.
• Approved for the first-line treatment of advanced renal cell carcinoma (RCC) in adults in combination with pembrolizumab (Keytruda), or in combination with everolimus (Afinitor) in those adults with advanced RCC following one prior anti-angiogenic treatment.
• May be given to people with inoperable hepatocellular (liver) carcinoma (HCC).
• For women with endometrial cancer who meet certain criteria, Lenvima may be given in conjunction with Keytruda. Criteria include the tumors are not MSI-H or dMMR, they cannot have curative surgery or radiation treatment, and their disease has progressed after other systemic therapies.
• Considered a targeted treatment, not a chemotherapy drug. Targeted drugs block tumor cell growth (cytostatic), whereas standard chemotherapy agents typically kill tumor cells directly (are cytotoxic).
• Available as an oral capsule (either 4mg or 10mg) that is taken once daily by mouth.
• May be taken with or without food.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• High blood pressure, fatigue, diarrhea, nausea, headache, rash, alopecia, cough, infection, insomnia, decreased appetite, weight loss, joint/muscle pain, abdominal pain, dysphonia (difficulty in speaking), protein in the urine, low thyroid hormone levels, and bleeding events (such as nose bleeds or blood in the urine)are the most common side effects reported. Approximately 3% of people experience hand-foot syndrome skin reaction (palmar-plantar erythrodysesthesia syndrome), symptoms include redness, swelling, and pain on the palms of the hands and/or the soles of the feet. Sometimes blisters appear.
• Hypertension was reported in 73% of patients receiving Lenvima 24mg once daily and 45% receiving 8mg or 12mg once daily. The average time to onset of new or worsening high blood pressure was 16 to 26 days. Control blood pressure before starting Lenvima and monitor after 1 week then every 2 weeks for the first 2 months and then at least monthly.
• Serious and fatal cardiac dysfunction can occur with Lenvima. Monitor patients for clinical symptoms or signs of cardiac dysfunction. Arterial thrombotic events, such as myocardial infarction and stroke have occurred in a small percentage of people taking Lenvima, especially when used in combination with pembrolizumab. Permanently discontinue Lenvima following one of these events and do not start within 6 months of an event.
• May impair wound healing and should be withheld at least one week before elective surgery.
• Osteonecrosis of the jaw has also been reported and may be more likely in those with other risk factors, such as bisphosphonate use, dental disease, or invasive dental procedures.
• Side effects led to a dose reduction or interruption in treatment in 62% of patients receiving lenvatinib, and led to lenvatinib treatment discontinuation in 20% of patients.
• The dosage of Lenvima needs to be reduced in those with severe kidney disease (less than 30 mL/min) or severe liver disease (Child-Pugh C) and also differs depending on the condition being treated. Renal impairment occurred in up to 14% of patients receiving Levnima and the risk is higher in those receiving everolimus, with diarrhea or dehydration. Serious hepatic events, such as hepatic failure or acute hepatitis) have occurred in up to 8% of patients treated with Lenvima. Monitor liver function prior to initiating Lenvima then every 2 weeks for the first 2 months and at least monthly thereafter.
• Proteinuria may also develop and Grade 3 proteinuria has been reported in 8% to 11% of patients. Withhold and resume at a reduced dose based on recovery or discontinue if severe. Fistulas and gastrointestinal perforation have also occurred; Levnima should be discontinued.
• Other notable side effects include QT/QTc interval prolongation (reported in 9% of Lenvima-treated patients with prolongation of >500ms occurring in 2%), hypocalcemia (65% of which resolved with calcium supplementation), and reversible posterior leukoencephalopathy syndrome in 0.3%.
• Monitor for the development of side effects. Lenvima may need to be withheld or the dosage reduced depending on the severity of the side effect. For example, for grade 3 hypertension, withhold or resume at a reduced dose once the hypertension is controlled at less than or equal to Grade 2. For Grade 4 hypertension, permanently discontinue Lenvima. See product information for a list of side effects and the course of action to take depending on the severity.
• Diarrhea has been reported in 49% of patients receiving Lenvima; 6% was severe (Grade 3). It was the most frequent cause of dose interruption or reduction while taking Lenvima and for at least 30 days afterward.
• The safety and effectiveness of Lenvima in children has not been established.
• Lenvima should not be used during pregnancy because it can cause fetal harm. Women of reproductive potential should use effective contraception during Lenvima treatment and for 30 days after the last dose. Although it is not known if Lenvima is present in human breast milk, it is present in rat milk at concentrations higher than those in maternal plasma. Women should discontinue breastfeeding during treatment and for at least 1 week after the last dose. May impair fertility in males and females.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Take Lenvima at the same time each day, with or without food. Swallow the capsule whole and do not chew, crush, or break it open. You may need to take it with other medications as prescribed by your doctor.
• Dosages may vary based on the type of cancer being treated or your weight. Follow your dosing instructions very carefully as you may need to take more than one capsule at a time to get your full prescribed dose.
• If you miss a dose of Lenvima, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.
• If you cannot swallow a whole capsule then you can dissolve Lenvima capsules. Measure one tablespoon of water or apple juice and pour the liquid into a small glass. Place the capsules (whole, not crushed or broken) into the liquid. Use only enough medicine for one dose. Allow the capsules to dissolve in the liquid for at least 10 minutes. Then, stir the mixture for at least 3 more minutes. Drink this mixture right away. Add a little more water or juice to the glass, swirl gently, and drink right away.
• Contact your doctor right away if you have vomiting or severe diarrhea. Prolonged illness can lead to dehydration (loss of body fluid) and kidney failure while you are taking Lenvima. You may need to take medicine to prevent diarrhea while you are using Lenvima and keep well hydrated. Carefully follow your doctor's instructions about when to start taking the anti-diarrhea medicine.
• How quickly Lenvima works for you depends upon many factors, such as your type of cancer, your cancer progression, other treatments you have received, and your overall health. Lenvatinib is usually given until your body no longer responds to the medication or the side effects become too severe to tolerate.
• Lenvima may increase your blood pressure and this needs to be monitored frequently, especially at the start of Lenvima treatment. Keep all your appointments with your health care provider as other monitoring (such as liver and kidney function) is also required.
• Tell your doctor if you have recently had a stroke or a heart attack, or any other cardiovascular event because Lenvima may not be suitable for you. Also tell your doctor if you develop any serious side effects such as headache, confusion, vision loss, seizures, or severe bleeding
• Do not take any other medications without your doctor's advice because Lenvima can interact with other medications.
• Tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding because Lenvima may not be suitable for you. You should use effective contraception while you are taking Lenvima and for 30 days after the last dose.

• Lenvima is taken until your body no longer responds to the medication or the side effects become too severe for you to tolerate. In safety studies conducted by the manufacturer, most patients took Lenvima for 6 to 16 months for the treatment of various types of cancer. Overall, 18% to 29% of patients had to stop treatment because of side effects they could not tolerate.
• The median treatment duration of Lenvima in thyroid cancer studies was 16.1 months. For the treatment of thyroid cancer, Lenvima-treated participants lived a median of 18.3 months without their disease progressing (progression-free survival or PFS), compared to a median of 3.6 months for participants who received a placebo.
• The median treatment duration of Lenvima in advanced kidney cancer studies was 16.1 months. In these studies, Lenvima and everolimus together resulted in a median PFS of 14.6 months for the combined treatment compared with 5.5 months in those patients who received everolimus alone.
• Lenvima is also approved for the treatment of unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be fully removed with surgery. The median treatment duration with Lenvima was at least 6 months in 49% of patients. In these studies, Lenvima was shown to be non-inferior to (not worse than) sorafenib (Nexavar) with a median overall survival of 13.6 months versus 12.3 months with sorafenib.
• In studies looking at the use of Lenvima plus Keytruda (pembrolizumab) for the treatment of patients with certain types of endometrial cancer, the median duration of study treatment was 7 months long but ranged up to 37.8 months. Sixty-nine percent of patients with endometrial cancer had a treatment response that lasted at least 6 months.
• Side effects can affect treatment time with Lenvima. 18% of patients with thyroid cancer permanently discontinued treatment due to severe side effects compared to 29% of patients with kidney cancer, 20% of those with liver cancer studies, and 21% with endometrial cancer studies. Fatal adverse reactions occurred in 3% of patients.

Medicines that interact with Lenvima may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Lenvima. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Lenvima interacts with over 260 drugs. Most of these interactions are considered major or moderate. Common medications that may interact with Lenvima include:

• amiodarone
• amisulpride
• antiandrogens, such as apalutamide and enzalutamide
• atomoxetine
• antipsychotics, such as clozapine, haloperidol, or risperidone
• buprenorphine
• black cohosh
• chloroquine or hydroxychloroquine
• disopyramide
• dronedarone
• droperidol
• erythromycin
• fingolimod
• HIV medications, such as efavirenz
• interferon
• ketoconazole
• laxatives such as bisacodyl or polyethylene glycol
• loperamide
• methadone
• metronidazole
• mifepristone
• ozanimod
• papaverine
• pimozide
• promethazine
• saquinavir
• SSRIs such as citalopram, fluoxetine, paroxetine, or sertraline
• tacrolimus
• tamoxifen
• targeted treatments such as cabozantinib and ceritinib
• tramadol
• venlafaxine
• zoledronic acid.

Lenvima may prolong the QT/QTc interval and coadministration with other medications that also prolong this interval should be avoided.

Note that this list is not all-inclusive and includes only common medications that may interact with Lenvima. You should refer to the prescribing information for Lenvima for a complete list of interactions.